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LMA

Question Type:
Intervention
Full Question:
In newborn infants at term that have indications for intermittent positive pressure for resuscitation  (P), does use of a laryngeal mask as a primary or secondary device  (I), compared with endotracheal intubation or mask ventilation improve response to resuscitation  (C), change  (O)?
Consensus on Science:
For comparison of laryngeal mask airway to face mask as a primary device (ie, use of laryngeal mask ventilation rather than bag-mask ventilation for infants at term requiring positive-pressure ventilation for resuscitation) we identified 3 randomized controlled trials enrolling a total of 469 patients: For the critical outcome of achieving vital signs, we identified low-quality evidence (downgraded for very serious risk of bias) from 2 small randomized clinical trials and 1 large quasi-randomized clinical trial (Singh 2005, 303; Feroze 2008, 148 Zhu 2011, 1405) showing that the laryngeal mask was more effective than the face mask (OR, 11.43; 95% CI, 4.01–32.58). For the critical outcome of need for subsequent endotracheal intubation after failed laryngeal mask or face mask, we identified low-quality evidence (downgraded for very serious risk of bias) from the same randomized clinical trials (Singh 2005, 303; Feroze 2008, 148; Zhu 2011, 1405) showing that the laryngeal mask was more effective than the face mask (OR, 0.13; 95% CI, 0.05–0.34). For the critical outcome of increasing Apgar Score, we have identified low-quality evidence from the same randomized controlled trials (downgraded for very serious risk of bias); the method of reporting precluded analysis of this outcome. We did not identify any evidence to address the critical outcomes of indicators of brain injury or long-term outcomes. For the important outcome of morbidity (gastric distention or vomiting), we identified low-quality evidence (downgraded for imprecision and very serious risk of bias) from the same randomized clinical trials (Singh 2005, 303; Feroze 2008, 148; Zhu 2011, 1405) showing no difference for any variable between the laryngeal mask and the face mask (OR, 5.76; 95% CI, 0.7–47.32). For comparison of laryngeal mask to endotracheal tube as a secondary device (ie, laryngeal mask or intubation when bag-mask ventilation has failed) for infants at term requiring positive-pressure ventilation for resuscitation (1 randomized clinical trial with 40 patients) (Esmail 2002, 115): For the critical outcome of achieving vital signs or successful resuscitation, we identified very-low-quality evidence (downgraded for imprecision, risk of bias) from 1 randomized clinical trial (Esmail 2002, 115) showing that laryngeal mask airway was as effective as the endotracheal tube. For the critical outcome of need for subsequent endotracheal intubation after failed bag-mask ventilation, we identified very-low-quality evidence (downgraded for imprecision, risk of bias) from the same randomized clinical trial (Esmail 2002, 115) showing that the laryngeal mask was as effective as the endotracheal tube. For the critical outcome of increasing Apgar score, we identified very-low-quality evidence (downgraded for imprecision and risk of bias) from the same randomized clinical trial (Esmail 2002, 115); the method of reporting precluded analysis of this outcome. For the critical outcome of mortality, we identified very-low-quality evidence (downgraded for imprecision and risk of bias) from the same randomized clinical trial (Esmail 2002, 115) showing no difference between the laryngeal mask or the endotracheal tube. We did not identify any evidence to address the critical outcome of indicators of brain injury or long-term neurologic outcomes comparing laryngeal mask airway or endotracheal tube as a secondary device. For the important outcome of morbidity, we identified very-low-quality evidence (downgraded for imprecision and risk of bias) from the same randomized clinical trial (Esmail 2002, 115) showing more trauma to tissue when comparing laryngeal mask versus endotracheal tube (OR, 2.43; 95% CI, 0.51–11.51).
Treatment Recommendation:
We suggest the laryngeal mask may be used as an alternative to tracheal intubation during resuscitation of the late-preterm and term newborn (more than 34 weeks) if ventilation via the face mask is unsuccessful (weak recommendation, low-quality evidence). In the unusual situation where intubation is not feasible after failed PPV, the laryngeal mask is recommended for resuscitation of the late-preterm and term newborn (more than 34 weeks) (strong recommendation, good clinical practice). Values, Preferences, and Task Force Insights In making these recommendations, we place a moderate value in the proven safety and feasibility for a laryngeal mask to provide ventilation in newborns while recognizing the necessity for more studies in other clinical settings (eg, premature infant). We also place high value on the idea that an alternative airway is a potentially lifesaving intervention when face-mask ventilation has failed and/or endotracheal intubation is unsuccessful or not feasible. There is now reasonable evidence to add a recommendation for the late-preterm infant.
CoSTR Attachments:
LMA GRADE CoSTR.docx    
LMA Summary of Bias Assessments.xlsx    
LMA vs ETT as secondary device.docx    
LMA vs FM as aprimary device.docx    

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